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NCT00462488 · ClinicalTrials.gov registry record · Phase 2

Study of Vicinium for Treating Patients With Non-Invasive Urothelial Carcinoma In Situ

A Phase 2 study, sponsored by Sesen Bio.

Completed
Registry status
Phase 2
Development phase
46
Enrollment target

NCT00462488: Completed Phase 2 study, sponsored by Sesen Bio.

NCT00462488 is a Phase 2 study that has completed, run by Sesen Bio. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00462488, a Phase 2 study, has completed, sponsored by Sesen Bio.

COMPLETED
Registry status
Phase 2
Development phase
46 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy and tolerability of Vicinium when administered as a monotherapy intravesical instillation in patients with non-invasive urothelial carcinoma in situ (CIS) who failed previous treatment with Bacille Calmette Guérin (BCG).

Primary Outcome

Complete response rate in subjects with carcinoma in situ (CIS) non-muscle invasive bladder cancer (NMIBC) following the induction phase (3-month evaluation point) of Vicinium treatment

Interventions

  • DRUG Vicinium

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2007-03
Est. Completion 2009-10
Phase Phase 2
Sesen Bio

3 total trials

What the finished NCT00462488 record still lists

NCT00462488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 1 intervention - of which Vicinium is the first listed.

NCT00462488 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00462488 about?

NCT00462488 is a clinical study titled "Study of Vicinium for Treating Patients With Non-Invasive Urothelial Carcinoma In Situ". The purpose of this study is to evaluate the efficacy and tolerability of Vicinium when administered as a monotherapy intravesical instillation in patients with non-invasive urothelial carcinoma in situ (CIS) who failed previous treatment with Bacille Calmette Guérin (BCG).

What is the current status of trial NCT00462488?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2007-03. Estimated completion is 2009-10.

What interventions are being tested in trial NCT00462488?

The interventions under investigation include: Vicinium (DRUG).

Who is sponsoring clinical trial NCT00462488?

This trial is sponsored by Sesen Bio, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00462488's enrollment target sits among peer trials

46 1286th of 2000 higher than 705 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00462488, the US trial registry maintained by the National Library of Medicine. NCT00462488 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.